MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT ULTRA SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RET

Model Number	M0068502160
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a mid-urethral sling and cystoscopy procedure using an advantage fit ultra system, the device did not function correctly when inserted into the patient.Another advantage fit ultra system device was used to complete the procedure.No patient complications were reported.This event has been deemed reportable based on the investigation finding that one of the dilators had separated from the sleeve.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Bock h11: with all the available information, boston scientific corporation concludes that the reported event of device damaged/defective is confirmed through product analysis.During visual investigation of the returned device, one of the dilators had separated from the sleeve.The sleeve was torn at the point where it begins to overlap with the dilator.No other defects were observed to the system, mesh, or delivery device.Upon receipt at our quality assurance laboratory, this advantage fit ultra system device underwent a thorough analysis.Based on the available information, it is likely that excessive pulling force was applied during the placement of the mesh, resulting in the analyzed device condition and the reported complaint.Therefore, the probable cause selected is adverse event related to procedure, which indicates that the adverse event occurred during the procedure and the device had no influence on the event.

• Brand Name: ADVANTAGE FIT ULTRA SYSTEM
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RET
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21938986
• Report Number: 2124215-2025-25022
• Device Sequence Number: 7837502
• Product Code: OTN
• UDI-Device Identifier: 00191506007669
• UDI-Public: (01)00191506007669(17)270513(10)34018859
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K231549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0068502160
• Device Catalogue Number: M0068502160
• Device Lot Number: 0034018859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown